CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,028 enrolled
Drug / intervention
tigecyclinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00488488
NCT00488488N/ACompleted

A Non-Interventional Study To Evaluate The Safety And Effectiveness Of Tygacil In The Treatment Of Patients With Complicated Intra-Abdominal Infections Or Complicated Skin And Skin Structure Infections

Pfizer·observational·Posted Jun 20, 2007·Updated Jul 22, 2011

In Brief

An observational study evaluating tigecycline for Infection. Completed, enrolled 1,028 participants.

Detailed Summary

To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to assess the main side effects observed in daily medical practice (Safety of Tygacil); to determine whether patients are optimally dosed with Tygacil (according to the label) and the proportion of patients receiving a monotherapy versus combination therapy; to observe the potential resistance development against Tygacil in Germany; to determine which antibiotic agents are chosen for a combination therapy with Tygacil; to determine to which antibiotic substance non-responders to Tygacil are switched; to assess the duration of the intravenous therapy with Tygacil and to determine whether and which patients receive an oral antibiotic substance after the therapy with Tygacil; to collect information on profile, comorbidities and characteristics of patients treated with Tygacil.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInfection
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2007
Enrollment StartNov 1, 2006
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.0 years ago

Interventions

tigecyclinedrug

The patients will be treated in accordance with the requirements of the labeling of tigecycline in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.